HD15 DIAGNOSTIC ULTRASOUND SYSTEM

K081661 · Philips Ultrasound, Inc. · IYN · Jun 24, 2008 · Radiology

Device Facts

• Record ID: K081661
• Device Name: HD15 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Philips Ultrasound, Inc.
• Product Code: IYN · Radiology
• Decision Date: Jun 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: [See individual transducer tables for specific clinical applications and modes of operation].

Device Story

HD15 Diagnostic Ultrasound System is a console-based diagnostic imaging device. It utilizes various transducers (e.g., 3D9-3v, C5-2, S5-2) to transmit electronic voltage pulses, which piezo-electric arrays convert into ultrasonic pressure waves. Reflected energy from body tissues is converted back into electrical signals. The system employs signal processing to generate images and Doppler shift analysis to display fluid flow. Operated by clinicians in clinical settings, the system provides real-time visualization and hemodynamic data to support diagnostic decision-making. It supports multiple modes including B-mode, M-mode, PWD, CWD, Color Doppler, 3D/4D, and Tissue Doppler Imaging. The device benefits patients by enabling non-invasive assessment of anatomy and blood flow.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing, including acoustic output measurements and verification of imaging/Doppler performance consistent with predicate devices.

Technological Characteristics

Console-based diagnostic ultrasound system. Uses piezo-electric transducer arrays. Modes: B, M, PWD, CWD, Color Doppler, 3D/4D, Tissue Doppler. Connectivity: System console with display and transducer ports. Electrical/physical safety: Complies with FDA Track 3 limits. Manufacturing: Quality systems per 21 CFR 820.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis of the human body, including fetal, abdominal, pediatric, small organ (thyroid, scrotum, breast), neonatal/adult cephalic, trans-rectal, trans-vaginal, trans-urethral, trans-esophageal, musculoskeletal, intra-luminal, gynecological, cardiac, and peripheral vessel applications. Prescription use only.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• HD11 Diagnostic Ultrasound System (K043535)
• HD11 Diagnostic Ultrasound System (K062247)

Submission Summary (Full Text)

{0}------------------------------------------------

510(k) Premarket Notification

### JUN 2 4 2008

#### 3.2 Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 as implemented in 21 C.F.R. 8807.92.

The submitter of this premarket notification is:

William Picatti Manager, Regulatory Affairs Philips Ultrasound, Inc. 22100 Bothell Everett Highway Bothell, WA 98021-8431 Tel: [phone] Fax: [phone]

This summary was prepared on May 12, 2009.

The proprietary name of the device is the HD15 Diagnostic Ultrasound System. In combination with transducers - 3D9-3v, BP10-5ec, C5-2, C6-3, C8-4v, C8-5, D2cwc, L 12-3, L 12-5, L 15-7io, S5-2, S8-3, S7-2omni and V6-2 - are commonly known as a diagnostic ultrasound system and transducers.

These devices are classified as follows:

| 90IYN | Ultrasonic Pulsed Doppler Imaging System |
|-------|------------------------------------------|
| 90IYO | Ultrasonic Pulsed Echo Imaging System |

- Diagnostic Ultrasound Transducer 90ITX
As stated in 21 CFR, parts 892.1550, 892.1560 and 892.1570, each of these generic types of devices have been classified as Class II.

The HD15 is a diagnostic ultrasound device. It consists of a system console containing the power supply and electronic circuitry required to generate the image, a display screen, and a connection to the separate transducers. It is substantially equivalent to the currently marketed HD11 Diagnostic Ultrasound System (K043535 and K062247).

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the text "K08166", "pg. 2 of 2", and "HD15 Diagnostic Ultrasound system". The text appears to be handwritten and typed. The text "K08166" and "pg. 2 of 2" are handwritten and are located at the top of the image. The text "HD15 Diagnostic Ultrasound system" is typed and is located at the bottom of the image.

The HD15 system and transducers function in a manner identical to all Philips ultrasound systems and transducers. The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo-electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The differing acoustic properties of the tissues in the body reflect some of the transmitted energy back to the transducer, where it is converted back to electrical signals and sent back to the system. In the system, advanced signal processing technologies convert the returned signals into images of the tissues. The Doppler functions of this system process the Doppler shift frequencies from the echoes of moving targets (such as blood), to detect and graphically display the Doppler shifts of these tissues as flow.

The HD15 is intended for diagnostic ultrasound imaging and fluid flow analysis.

The HD15 is substantially equivalent in safety and effectiveness to the predicates identified above:

- . Both the predicate device and the HD15 are indicated for the diagnostic ultrasonic imaging and fluid flow analysis.
- . Both the predicate device and the HD15 have the same gray-scale and Doppler capabilities.
- Both the predicate device and the HD15 use essentially the same technologies for . imaging, Doppler functions and signal processing.
- . Both the predicate device and the HD15 have acoustic output levels below the Track 3 FDA limits.
- . Both the predicate device and the HD15 are manufactured under equivalent quality systems.
- . Both the predicate device and the HD15 are manufactured of materials with equivalent biosafety. The materials have been evaluated and found to be safe for this application.
- � Both the predicate device and HD15 are designed and manufactured to the same electrical and physical safety standards.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 2008

Philips Ultrasound, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K081661

Trade/Device Name: Philips Ultrasound, Inc. HD15 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: June 12, 2008 Received: June 13, 2008

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the Philips Ultrasound, Inc. HD15 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

3D9-3v 4D Endovaginal BP10-5ec Endocavity C5-2 Curved Linear Array C6-3 Curved Linear (C8-4v) Endovaginal C8-5 Curved Linear

{3}------------------------------------------------

D2cwc Non-image Pencil L12-3 Linear Array L12-5 50mm Linear Array L15-7io Linear Array S5-2 Sector Phased Array S7-2 omni TEE Phased Array S8-3 Sector Phased Array V6-2 Mechanical 3D

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set 1 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

{4}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Lauren Hefner at [phone].

Sincerely yours,

loni M Whay

lancy C. Brogdon E Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

{5}------------------------------------------------

#### 4.3.2 Indications for Use Tables

### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

# K081661

Philips Ultrasound, Inc. HD15 Diagnostic Ultrasound System Device name: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|-------------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | N | N | N | N | N | N | N |
| | Fetal | N | N | N | N | N | N | N |
| | Abdominal | N | N | N | N | N | N | N |
| | Intra-operative<br>(vascular/epicardial) | N | N | N | N | N | N | N |
| | Intra-operative (Neuro) | N | N | N | N | N | N | N |
| | Laparoscopic | N | N | N | N | N | N | N |
| Fetal Imaging<br>& Other | Pediatric | N | N | N | N | N | N | N |
| | Small Organ (thyroid,<br>scrotum, breast) | N | N | N | N | N | N | N |
| | Neonatal Cephalic | N | N | N | N | N | N | N |
| | Adult Cephalic | N | N | N | N | N | N | N |
| | Trans-rectal | N | N | N | N | N | N | N |
| | Trans-vaginal | N | N | N | N | N | N | N |
| | Trans-urethral | N | N | N | N | N | N | N |
| | Trans-esoph. (non-Card.) | N | N | N | N | N | N | N |
| | Musculo-skel (conventional) | N | N | N | N | N | N | N |
| | Musculo-skel (superficial) | N | N | N | N | N | N | N |
| | Intra-luminal | N | N | N | N | N | N | N |
| | Other (Gynecological) | N | N | N | N | N | N | N |
| | Cardiac Adult | N | N | N | N | N | N | N |
| Cardiac | Cardiac Pediatric | N | N | N | N | N | N | N |
| | Trans-esoph. (Cardiac) | N | N | N | N | N | N | N |
| | Other (specify) | N | N | N | N | N | N | N |
| Peripheral<br>Vessel | Peripheral vessel | N | N | N | N | N | N | N |
| | Other (Carotid, I/O) | N | N | N | N | N | N | N |

= new indication; P= previously cleared by FDA; E=added under Appendix E

*Other modes: Panoramic, Color Power Angio (CPA, formerly Angio), 3D/4D, Harmonics (Tissue and Contrast), Directional Angio Imaging, Tissue Doppler Imaging.

Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Signature Sign Off

{6}------------------------------------------------

208166 510(k) Number:

System: Philips Ultrasound, Inc. HD15 Diagnostic Ultrasound System

Transducer: 3D9-3v 4D Endovaginal transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | Mode of Operation | | | | | | | |
|--------------------------------------------------------------------------------------|------------------------------|---|---|-----|-----|------------------|-----------------------|---------------------|
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | P | P |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | | | | | | | |
| | Small Organ (Prostate) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | P | P | P | | P | P | P |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| Cardiac | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |
| N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | | |
| *Other modes: Color Power Angio, Panoramic, 3D/4D Imaging, Directional Angio Imaging | | | | | | | | |
| Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color | | | | | | | | |
| Previous submission: First use on this ultrasound system (See 4.4.1.4) | | | | | | | | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Arque Arthing

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

{7}------------------------------------------------

### DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

# 1081661

System: Philips Ultrasound, Inc. HD15 Diagnostic Ultrasound System

Transducer: BP10-5ec Endocavity transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | P | P |
| | Abdominal | | | | | | | |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | | | | | | | |
| | Small Organ (scrotum) | P | P | P | | P | P | P |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | P | P | P |
| | Trans-vaginal | P | P | P | | P | P | P |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Carotid, I/O) | | | | | | | |
| N= new indication; P= previously cleared by FDA; E= added under Appendix E<br>*Other modes: Color Power Angio, Panoramic, Harmonics (Tissue & Contrast), 3D/4D Imaging, Directional Angio<br>Imaging, Tissue Doppler Imaging | | | | | | | | |

Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color

Previous submission: First use on this ultrasound system (See 4.4.1.4)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

lonai Th. Whang

Islon of Reproductive, Abdominal, a adiological ! 610(k) N

{8}------------------------------------------------

510(k) Number: System: Philips Ultrasound, Inc. HD15 Diagnostic Ultrasound System

Transducer: C5-2 Curved linear array transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | | Mode of Operation | | | | | |
|---------------------------|-------------------------------------------------------------------------------------------------------------|---|-------------------|-----|-----|------------------|-----------------------|---------------------|
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | P | P | P | | P | P | P |
| | Abdominal | P | P | P | | P | P | P |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | P |
| | Small Organ (thyroid,<br>scrotum, breast) | P | P | P | | P | P | P |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Gynecological) | P | P | P | | P | P | P |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | P | P |
| | Other (Carotid, I/O) | | | | | | | |
| | N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | |
| | *Other modes: Color Power Angio, Panoramic, Harmonics (Tissue & Contrast), 3D/4D Imaging, Directional Angio | | | | | | | |

Imaging,

Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color Previous submission: First use on this ultrasound system (See 4.4.1.4)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

Aomi McWhan

(Division Sign-Off) Division of Reproductive, Abdomina Radiological Devices 510(k) Number

{9}------------------------------------------------

Cardiac

Peripheral

Vessel

| 510(k) Number: | 19081641 | | | | | | | |
|---------------------------|--------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| System: | Philips Ultrasound, Inc. HD15 Diagnostic Ultrasound System | | | | | | | |
| Transducer: | C6-3 Curved linear Transducer | | | | | | | |
| | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | P | P | P |
| | Abdominal | P | P | P | | P | P | P |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | P | P | P | | P | P | P |
| | Small Organ (thyroid,<br>scrotum, breast) | P | P | P | | P | P | P |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM 120811000

N= new indication; P= previously cleared by FDA; E= added under Appendix E *Other modes: Color Power Angio, Panoramic, Harmonics (Tissue & Contrast), 3D/4D Imaging, Directional Angio

P

P

P

Imaging, Combined modes: Duplex = 2D + Doppler; Triplex = 2D + Doppler + Color, Dual

P

P

P

P

P

P

P

P

P

Previous submission: First use on this ultrasound system (See 4.4.1.4)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEBDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

Intra-luminal

Other (Gynecological) Cardiac Adult

Cardiac Pediatric Trans-esoph. (Cardiac) Other (Specify)

Peripheral vessel

Other (Carotid, VO)

Aoru Tn Whan

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

{10}------------------------------------------------

1081661 510(k) Number:

System: Philips Ultrasound, Inc. HD15 Diagnostic Ultrasound System

Transducer: (C8-4v) Endovaginal transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|--------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | P | P | P | | P | P | P |
| | Abdominal | | | | | | | |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (thyroid,<br>scrotum, breast) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | P | P | P | | P | P | P |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Carotid, I/O) | | | | | | | |
| | N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | |
| | *Other modes: Color Power Angio, Panoramic, 3D/4D Imaging, Directional Angio Imaging | | | | | | | |
| | Combined modes: Duplex = 2D + Doppler, Triplex = 2D + Doppler + Color | | | | | | | |
| | Previous submission: First use on this ultrasound system (See 4 4 1 4) | | | | | | | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Arzu M. Khan

(Division Sign-Off) ision of Reproductive, Abdominal, and Radiological Devices 510(k) Number

{11}------------------------------------------------

#### K081661 510(k) Number:

System: Philips Ultrasound, Inc. HD15 Diagnostic Ultrasound System

Transducer: C8-5 Curved linear Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | P | P | P | | P | P | P |
| | Abdominal | P | P | P | | P | P | P |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | P | P | P | | P | P | P |
| | Small Organ (thyroid,<br>scrotum, breast) | | | | | | | |
| | Neonatal Cephalic | P | P | P | | P | P | P |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Gynecological) | P | P | P | | P | P | P |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | P | P | P |
| | Other (Carotid, I/O) | | | | | | | |
| N= new indication; P= previously cleared by FDA; E= added under Appendix E<br>*Other modes: Color Power Angio, Panoramic, 3D/4D Imaging, Harmonics (Tissue), Directional Angio Imaging,<br>Tissue Doppler Imaging | | | | | | | | |

Combined modes: Duplex = 2D + Doppler, Triplex = 2D + Doppler + Color, Dual

Previous submission: First use on this ultrasound system (See 4.4.1.4)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

Arzne M. Whtz

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

{12}------------------------------------------------

510(k) Number:

System: Philips Ultrasound, Inc. HD15 Diagnostic Ultrasound System

Transducer: D2cwc Non-Imaging Pencil

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General | Specific | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| (Track I Only) | (Tracks I & III) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | | | | | | | |
| | Small Organ (thyroid,<br>scrotum, breast) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel (conventional) | | | | | | | |
| | Musculo-skel (superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Gynecological) | | | | | | | |
| | Cardiac Adult | | | | P | | | |
| Cardiac | Cardiac Pediatric | | | | P | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Carotid, I/O) | | | | | | | |
| N= new indication; P= previously cleared by FDA; E= added under Appendix E<br>*Other modes include: None<br>Combined modes: None.<br>Previous submission: First use on this ultrasound system (See 4.4.1.4) | | | | | | | | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

Sidn-Off Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

{13}------------------------------------------------

510(k) Number: System: Philips Ultrasound, Inc. HD15 Diagnostic Ultrasound System

Transducer: L12-3 Linear array transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | |
|---------------------------|-------------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|---------------------|
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | P | P | P | | P | P | P |
| | Intra-operative<br>(vascular/epicardial) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | P | P | P | | P | P | P |
| | Small Organ (thyroid,<br>scrotum, breast) | P | P | P | | P | P | P |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel (conventional) | P | P | P | | P | P | P |
| | Musculo-skel (superficial) | P | P | P | | P | P | P |
| | Intra-luminal | | | | | | | |
| | Other (Gynecological) | | | | | |…